Indwelling assembly

ABSTRACT

An indwelling assembly includes an inner needle having a sharp needlepoint, an inner needle hub fixed to the inner needle, a hollow elongated outer member in which the inner needle is positioned and movable in a distal direction relative to the inner needle after puncturing the blood vessel to position the elongated outer member at a desired position in the blood vessel, an outer member hub fixed to hollow elongated outer member, a projection removably connected to the outer member hub and configured to be engaged by a finger of the user to apply a force to the projection causing the outer member hub and the hollow elongated outer member to move together with the projection in the distal direction relative to the inner needle and the inner needle hub, and an elongated movable member that is movable relative to the hollow elongated outer member and the outer member hub.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation U.S. application Ser. No. 14/497,364filed Sep. 26, 2014, which is a continuation of U.S. application Ser.No. 13/627,385 filed Sep. 26, 2012, now U.S. Pat. No. 8,876,773, whichis a continuation of International Application No. PCT/JP2011/057010filed on Mar. 23, 2011, and claims priority to Japanese PatentApplication No. 2010-073414 filed on Mar. 26, 2010 and Japanese PatentApplication No. 2010-122413 filed on May 28, 2010, the entire content ofeach of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to an indwelling assembly.

BACKGROUND DISCUSSION

In performing infusion into a patient or in other similar situations, anindwelling needle connected to an infusion line is made to puncture apatient's blood vessel and indwell in situ, so that the desiredoperation can be conducted.

An indwelling needle (indwelling needle assembly) includes a hollowouter needle used as a peripheral vein catheter, an outer needle hubfirmly attached to the proximal end (base end) of the outer needle, aninner needle which is inserted in the outer needle and which has a sharpneedlepoint at the distal end (tip) thereof, and an inner needle hubfirmly attached to the proximal end of the inner needle. An example isdisclosed in Japanese Patent Laid-open No. 2009-232916.

At the time of puncture of a patient's blood vessel by the indwellingneedle, the puncturing operation is conducted in an assembled statewherein the inner needle is inserted in the outer needle and theneedlepoint of the inner needle protrudes from the distal end of theouter needle.

When the needlepoint of the inner needle has reached the inside of theblood vessel, blood flowing in via an opening at the needlepoint passesthrough the lumen of the inner needle, and flows into the inside of thetransparent inner needle hub (flashback). This helps enable the operatorto confirm (visually confirm) that the inner needle has securelypunctured the blood vessel.

After confirmation of the flashback, the outer needle is advanced, withthe inner needle as a guide, and the outer needle is inserted into (madeto puncture) the blood vessel.

Next, the inner needle is pulled out of the outer needle, a connector ofthe infusion line is connected to the outer needle hub, and an infusionliquid is dispensed.

Meanwhile, as a catheter which is longer than the above-mentionedperipheral vein catheter and is placed indwelling into a patient's bloodvessel for dosing the patient with an infusion, for example, a centralvein catheter, a PICC (Peripherally Inserted Central Catheter), amidline catheter and the like.

In order to put such a catheter indwelling in a patient's blood vessel,first, an introduction needle is made to puncture the patient's bloodvessel. The puncture by the introduction needle is conducted by usingthe outer needle as the introduction needle. Then, the catheter is fedinto the introduction needle, which places the catheter indwelling inthe patient.

However, the procedure of indwelling the above-mentioned catheter in ablood vessel is relatively more complicated than the procedure ofindwelling the above-mentioned outer needle in the blood vessel.

The lengths of the inner needle and the outer needle of the indwellingneedle assembly can be selected to be large and to use the outer needleas the central vein catheter, PICC, or midline catheter.

When the lengths of the inner needle and the outer needle are selectedto be relatively large, however, at the time of a puncturing operation,the inner needle and the outer needle may be deflected, making thepuncturing relatively difficult. For example, where the inner needle isrelatively thin and the inner needle and the outer needle are relativelyeasily deflected, it can be relatively difficult to achieve puncture.

SUMMARY

According to one aspect, an indwelling assembly includes: an innerneedle having a sharp needlepoint at a distal end to puncture a bloodvessel of a patient when the indwelling assembly is moved toward thepatient; an inner needle hub fixed to the proximal portion of the innerneedle; a hollow elongated outer member in which the inner needle ispositioned, with the hollow elongated member being movable in a distaldirection relative to the inner needle after puncturing the patient'sblood vessel with the sharp needlepoint to position the hollow elongatedouter member at a desired position in the blood vessel; an outer memberhub fixed to the proximal portion of the hollow elongated outer member;a projection removably connected to the outer member hub and configuredto be engaged by a finger of the user to apply a force to the projectioncausing the outer member hub and the hollow elongated outer member tomove together with the projection in the distal direction relative tothe inner needle and the inner needle hub. The projection is removablyconnected to the outer member hub so that the projection is detachablefrom the outer member hub. The indwelling assembly also includes anelongated movable member that is movable relative to the hollowelongated outer member and the outer member hub, the elongated movablemember being connected to the inner needle hub so that the inner needlehub, the inner needle and the elongated movable member move together,with the elongated movable member projecting in the distal directionfrom the inner needle hub. The elongated movable member is movabletogether with the inner needle hub and the inner needle in a proximaldirection relative to the hollow elongated outer member and the outermember hub after the hollow elongated outer member is positioned in thepatient's blood vessel to remove the inner needle from the patient'sblood vessel while the hollow elongated outer member remains positionedin the patient's blood vessel and to entirely remove the inner needlefrom the hollow elongated outer member.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a cross-sectional view showing a first embodiment of anindwelling needle assembly.

FIG. 2 is a cross-sectional view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 1.

FIG. 3 is a cross-sectional view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 1.

FIG. 4 is a cross-sectional view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 1.

FIGS. 5 a-5 c are cross-sectional views illustrating an example of amethod of using the indwelling needle assembly shown in FIG. 1.

FIG. 6 is a perspective view of a second embodiment (assembled state) ofan indwelling needle assembly.

FIG. 7 is a perspective view of the second embodiment (non-assembledstate) of the indwelling needle assembly.

FIG. 8 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 6.

FIG. 9 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 6.

FIG. 10 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 6.

FIGS. 11 a and 11 b are perspective views illustrating an example of amethod of using the indwelling needle assembly shown in FIG. 6.

FIG. 12 is a perspective view of a third embodiment (assembled state) ofan indwelling needle assembly.

FIG. 13 is a side view of a pressing member of the indwelling needleassembly shown in FIG. 12.

FIG. 14 is a side view of the pressing member and an outer needle of theindwelling needle assembly shown in FIG. 12.

FIG. 15 is a front view of the indwelling needle assembly shown in FIG.12.

FIG. 16 is a perspective view of the pressing member and a distalportion of a grip member of the indwelling needle assembly shown in FIG.12.

FIGS. 17 a-d show perspective views of an outer needle hub and thepressing member of the indwelling needle assembly shown in FIG. 12.

FIG. 18 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 12.

FIG. 19 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 12.

FIG. 20 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 12.

FIG. 21 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 12.

FIG. 22 is a perspective view illustrating an example of a method ofusing the indwelling needle assembly shown in FIG. 12.

DETAILED DESCRIPTION

Set forth below, with reference to the accompanying drawings, is adetailed description of several embodiments of an indwelling needleassembly and method of use representing examples of the indwellingneedle assembly and method disclosed here.

In the following example, description will be made by referring to theleft side in FIGS. 1 to 5 as the “proximal (end)” or rear end, the rightside as the “distal (end)” or front end, the upper side as the “upper”and the lower side as the “lower.”

As shown in FIG. 1, the indwelling needle assembly 1 includes a hollowouter needle 2, an outer needle hub 3 fixed to a proximal portion of theouter needle 2, an inner needle 4 inserted in the outer needle 2, aninner needle hub 5 fixed to a proximal portion of the inner needle 4,and a pressing member 6 connected to the outer needle hub 3.

By way of example, the outer needle 2 has a certain degree offlexibility. For example, the material constituting the outer needle 2is a resin material, such as a flexible resin material. Examples of theresin material include fluoro-resins such as PTFE, ETFE, PFA, etc.,olefin reins such as polyethylene, polypropylene, etc. or mixturesthereof, polyurethane, polyesters, polyamides, polyether-nylon resins,mixtures of the olefin resin with an ethylene-vinyl acetate copolymer,and the like.

An outer needle 2 as disclosed may have inside visibility at the wholepart or a part thereof. Besides, the material forming the outer needle 2may be admixed with a radiopaque material, e.g., barium sulfate, bariumcarbonate, bismuth carbonate, or tungstic acid, whereby a radiopaquecontrast function can be imparted to the material.

In addition, the length L1 of the outer needle 2 is not limited and canbe set appropriately according to the use or various conditions. By wayof example, the length L1 of the outer needle 2 can be set in the rangeof about 2.0 to 50.0 cm, for example, about 3.0 to 40.0 cm, and forexample, about 10.0 to 30.0 cm.

The length L1 of the outer needle 2 helps ensure that the outer needle 2can be used as a catheter which is longer than peripheral veincatheters, such as, for example, a central vein catheter, a PICC, or amidline catheter. Incidentally, the outer needle 2 may naturally be usedas a peripheral vein catheter.

To a proximal portion of the outer needle 2, the outer needle hub 3 isattachable, for example, firmly attached or fixed, in a liquid-tightmanner by such a method as caulking, welding (heat welding, microwavewelding, etc.), or adhesion with an adhesive.

The outer needle hub 3 is composed of a substantially tubular member,and the inside thereof communicates with a lumen 21 of the outer needle2. Besides, the outer needle hub 3 is formed with a flange 31 at anouter circumferential part of a proximal portion of the outer needle hub3.

In the outer needle 2 is inserted the inner needle 4 which has a sharpneedlepoint 41 at its distal end. The indwelling needle assembly 1 isused in the state in which the inner needle 4 is inserted in the outerneedle 2 and an inner needle hub 5 to be disclosed later is fitted tothe outer needle hub 3 (the state in which the needlepoint 41 protrudesfrom a distal opening 22 of the outer needle 2), namely, in the state asshown in FIGS. 1 and 2. By way of example, this state will be referredto as “the assembled state”

The length of the inner needle 4 is so set that, in the assembled state,at least the needlepoint 41 protrudes from the distal opening 22 of theouter needle 2.

The inner needle 4 may be a hollow needle, and may also be a solidneedle. Where the inner needle 4 is a solid needle, relativelysufficient strength can be secured while setting the outside diameter ofthe inner needle 4 small. In addition, where the inner needle 4 is asolid needle, the solid needle helps ensure that in discarding the innerneedle 4 after an operation is finished, such a risk as remaining ofblood inside the inner needle 4 or flowing-out of the remaining blood isrelatively absent, so that relatively high safety is secured.

By way of example, where the inner needle 4 is a hollow needle, uponpuncture of a blood vessel by the inner needle 4 blood flows into thehollow part of the inner needle 4 and the flashback of the blood isconfirmed by the user. In this connection, where the inner needle 4 is asolid needle, blood flows into the gap between the inner needle 4 andthe outer needle 2, so that the flashback of the blood can be confirmedmore swiftly.

For example, while the inner needle 4 may have a configuration in whichit has both a hollow part and a solid part (e.g., a configuration inwhich the lumen of a hollow needle is partly filled so that the needleis hollow on the distal side and solid on the proximal side), aconfiguration in which the whole body of the inner needle 4 is composedof a single member helps reduce the cost of the inner needle 4.

In addition, the inner needle 4 may be constant in outside diameter, ormay have plural (in this embodiment, three) parts which are different inoutside diameter.

Examples of the material constituting such an inner needle 4 asabove-mentioned include metallic materials such as stainless steel,aluminum or aluminum alloys, and titanium or titanium alloys.

By way of example, the inner needle 4 is such that when its partcorresponding to a pressing section 64 of the pressing member 6 to bedisclosed later (its part to be pressed by the pressing section 64) isfixed and a force of about 0.1 N in a direction perpendicular to theaxis of the inner needle 4 is exerted on its distal portion, thedisplacement of the distal portion in the direction perpendicular to theaxis of the inner needle 4 will be not more than about 3.0 mm, forexample not more than about 2.0 mm.

The inner needle hub 5 can be fixed to a proximal portion of the innerneedle 4.

The inner needle hub 5 is composed of a substantially tubular member,and a flange 51 is formed at an outer circumferential part of a proximalportion thereof. In the assembled state, that part of the inner needlehub 5 which is on the distal side relative to the flange 51 is insertedin the inside of the outer needle hub 3, and is fitted and fixed there.

For example, at a proximal-side opening of the inner needle hub 5, avent filter 52 is disposed so as to cover the opening. The vent filter52 has such a property as to permit gas to pass therethrough, and blockthe passage of liquid therethrough.

Examples of the vent filter 52 include various sintered porous bodies,hydrophobic non-woven fabrics, and other porous bodies. For example, thesintered porous bodies are those obtained by sintering a materialcontaining a polymer material (powder) such as polyethylene and ahydrophilic (water-soluble, or water-swellable) polymer. When thesintered porous body is used, its contact with liquid (blood) blocksventilation as well, which helps prevent the external intrusion of air.For example, where the inner needle 4 is a solid needle, it isunnecessary to provide the vent filter 52.

Examples of the method for fixing the inner needle 4 to the inner needlehub 5 include such method as fitting, caulking, welding, or adhesionwith an adhesive, and combinations of these methods.

By way of example, an inner needle hub 5 and the above-disclosedmentioned outer needle hub 3 can be formed respectively from transparent(colorless transparent), colored transparent or semi-transparent resins,whereby visibility of the inside thereof is secured. This helps ensurethat when the outer needle 2 has securely reached the inside of a bloodvessel, the flashback of blood flowing in can be confirmed by visualobservation.

Materials constituting the outer needle hub 3 and the inner needle hub 5are not restricted. Examples of the materials include various resinmaterials such as polyolefins such as polyethylene, polypropylene,ethylene-vinyl acetate copolymer, etc., polyurethane, polyamides,polyesters, polycarbonate, polybutadiene, polyvinyl chloride, andpolyacetal.

The pressing member 6 has the pressing section 64 which is pressed by afinger against that part (intermediate part) of the outer needle 2between the proximal end and the distal end of the outer needle 2, atthe time of a puncturing operation of causing the needlepoint 41 of theinner needle 4 and a distal portion of the outer needle 2 in theassembled state to puncture a blood vessel, in a process for setting theouter needle 2 indwelling in the blood vessel. By the pressing section64, that part of the outer needle 2 between the proximal end and thedistal end is pressed.

For example, the pressing member 6 includes an elongate main bodysection 61 disposed along the axis (center axis) of the outer needle 2and located on the outer needle 2, a finger hook projection 62 which isprovided in the main body section 61 and on which a finger is placed,and the pressing section 64 composed of that part of the main bodysection 61 which is on the opposite side in the vertical direction fromthe finger hook projection 62. The finger hook projection 62 is formedat a distal portion of the main body section 61 so as to project upward.Those parts of the finger hook projection 62 and the main body section61 which are to be contacted by a finger are, for example, flatsurfaces, or curved recessed surfaces, or curved protuberant surfaces.An upper-side part of the pressing member 6 constitutes a finger contactsection on which a finger is placed.

By way of example, while the pressing section 64 is provided byutilizing the distal portion of the main body section 61 of the presentembodiment. For example, the pressing section 64 may be composed of aprojection formed at that part of the main body section 61 which is onthe opposite side in the vertical direction from the finger hookprojection 62.

In addition, a proximal portion of the pressing member 6, or a proximalportion of the main body section 61, is connected to the outer needlehub 3. This structure helps enable the finger hook projection 62 toserve also as a part to be pressed by a finger at the time of moving theouter needle 2 in the distal direction relative to the inner needle 4,in the process of putting the outer needle 2 indwelling in a bloodvessel. For example, the pressing member 6 naturally may be connected toother member, such as the inner needle hub 5.

The pressing member 6 can be connected to the outer needle hub 3 in sucha manner as to be turnable (displaceable) relative to the outer needlehub 3. For example, a hinge structure section is composed of a shaft 63provided at a proximal portion of the main body section 61, and abearing 32 provided on the upper portion of the outer surface of theouter needle hub 3 for supporting the shaft 63, and, owing to the hingestructure section, the pressing member 6 can be turned relative to theouter needle hub 3, with the proximal portion of the main body section61 as a center of turning.

In addition, the pressing member 6 is configured to be displaceable intoa first position shown in FIG. 1 where it is disposed along the axis ofthe outer needle 2 and a second position shown in FIG. 5( a) where it isretracted from the outer needle 2.

When the pressing member 6 is situated in the first position, thepressing member 6 is located on the outer needle 2. In addition, thedistal portion of the pressing member 6, or the finger hook projection62 and the pressing section 64 are located on the distal side relativeto the proximal portion of the outer needle 2 and on the proximal siderelative to the distal portion of the outer needle 2. This configurationhelps ensure that even in the case where the inner needle 4 and theouter needle 2 are comparatively large in length, at the time of apuncturing operation, by pressing down that part of the outer needle 2between the proximal end and the distal end (that part of the outerneedle 2 corresponding to the pressing section 64 of the pressing member6) through the pressing section 64, to restrain the inner needle 4 andthe outer needle 2 from deflection and to carry out the puncturingoperation relatively easily and assuredly.

By way of example, since the puncturing operation can be performed byputting the finger on the finger hook projection 62 of the pressingmember 6 that is located nearer to the distal portions of the innerneedle 4 and the outer needle 2 than the inner needle hub 5 and theouter needle hub 3, the needlepoint 41 of the inner needle 4 can becontrolled relatively easily during the puncturing operation.

In addition, when the pressing member 6 is situated in the secondposition, the pressing member 6 is located on the proximal side relativeto the outer needle 2. The pressing member 6 can be moved into thissecond position, in the case where the pressing member 6 would otherwisebe an obstacle to the operator (user) or the patient (the person forwhich the assembly is used) during the process of putting the outerneedle 2 indwelling in a blood vessel or after the outer needle 2 is putindwelling in the blood vessel or in other similar situation.

For example, the pressing member 6 is configured to be attachable to anddetachable from the outer needle hub 3. The shaft 63 is provided at aproximal portion of the main body section 61 and can be detachablyattached to the bearing 32 provided in the outer needle hub 3. Thisconfiguration helps enable the pressing member 6 to be detached in thecase where the pressing member 6 would otherwise be an obstacle to theoperator or the patient during the process of putting the outer needle 2indwelling in a blood vessel or after the outer needle 2 is putindwelling in the blood vessel or in other similar situation. Inaddition, when the pressing member 6 becomes necessary, the pressingmember 6 can be attached.

By way of example, the dimensions of the pressing member 6 are notlimited, insofar as that part of the outer needle 2 between the proximalend and the distal end can be pressed by the pressing section 64 of thepressing member 6.

In addition, the pressing member 6 can be sized that when the pressingmember 6 is pressed by a finger, the finger does not touch the outerneedle 2, which enhances safety. For example, the outer needle 2 as wellas the parts to be brought into contact with the outer needle 2, such asa back surface of the pressing member 6, is in a sterilized state.

The material constituting the pressing member 6 is not restricted, andfor example, the same or similar materials to those mentioned asexamples of the materials for forming the outer needle hub 3 and theinner needle hub 5 above can be used.

According to an aspect, a method of using the indwelling needle assembly1 (in the case of puncturing a blood vessel) (operation) is disclosedbelow.

As shown in FIG. 2, the indwelling needle assembly 1 is put into theassembled state, and the pressing member 6 is positioned in the firstposition. The inner needle hub 5 is gripped by one hand, and an indexfinger is put on the finger hook projection 62 of the pressing member 6.While pressing down the vicinity of a base part of the finger hookprojection 62 by the index finger, a distal portion of the indwellingneedle assembly 1 (the united distal portion of the outer needle 2 andthe inner needle 4) is made to puncture a skin of a patient toward ablood vessel, in the manner of pressing the united distal portionagainst the patient. In this instance, as above-mentioned, the pressingsection 64 presses down that part of the outer needle 2 between theproximal end and the distal end, whereby the inner needle 4 and theouter needle 2 can be restrained from deflection. Incidentally, theinner needle hub 5 naturally may be gripped by the left hand.

When the needlepoint 41 of the inner needle 4 has punctured the bloodvessel, the blood pressure causes blood to flow back in the proximaldirection through the inner needle 4, to be introduced into the innerneedle hub 5, and this flashback can be visually confirmed through theinner needle hub 5 having visibility. As a result, one can know that theneedlepoint 41 of the inner needle 4 has relatively securely puncturedthe blood vessel.

Incidentally, attendant on the inflow of the blood, air in the innerneedle hub 5 is discharged via the vent filter 52. However, since theblood does not pass through the vent filter 52, this helps ensure thatthe blood does not leak to the exterior.

As shown in FIG. 3, the outer needle 2 is advanced further by a minutedistance in the distal direction along the inner needle 4, with theinner needle 4 as a guide. For example, the finger hook projection 62 ispushed in the distal direction by the index finger, to move the outerneedle 2 in the distal direction.

Subsequently, as shown in FIG. 4, while fixing the position of the innerneedle hub 5 with the other hand, the outer needle hub 3 is gripped, andthe outer needle 2 is advanced further in the distal direction along theinner needle 4, with the inner needle 4 as a guide. In this manner, adistal portion of the outer needle 2 is inserted to a target position inthe blood vessel.

Next, while holding down by the left hand the outer needle hub 3 and thepressing member 6 on the side of the outer needle 2 kept indwelling inthe blood vessel, the inner needle hub 5 is gripped by the right handand is pulled in the proximal direction. This results in that the innerneedle 4 is pulled out of the outer needle 2. After the inner needle 4is thus pulled out of the outer needle 2, if necessary, as shown in FIG.5( a), the pressing member 6 may be positioned into the second positionby turning. Alternatively, as shown in FIG. 5( b), the pressing member 6may be detached from the outer needle hub 3. Further, as shown in FIG.5( c), the pressing member 6 may be left as it is.

To the outer needle hub 3 from which the inner needle 4 has been pulledout, a connector of an infusion set (not shown) is relatively quicklyconnected, and dispensing of an infusion liquid is started following thenormal procedure.

After the inner needle 4 is pulled out of the outer needle 2 inaccordance with this embodiment, the inner needle 4 and the inner needlehub 5 are unnecessary and can be disposed of.

As disclosed above, according to the indwelling needle assembly 1, inthe embodiment where the inner needle 4 and the outer needle 2 arecomparatively large in length, by pressing down that part of the outerneedle 2 between the proximal end and the distal end through thepressing section 64 of the pressing member 6 at the time of a puncturingoperation, to relatively restrain the inner needle 4 and the outerneedle 2 from deflection and to carry out the puncturing operationrelatively easily and assuredly.

In addition, since the puncturing operation can be conducted by puttinga finger on the finger hook projection 62 of the pressing member 6 thatis nearer to the distal portions of the inner needle 4 and the outerneedle 2 than the inner needle hub 5 and the outer needle hub 3, theneedlepoint 41 of the inner needle 4 can be controlled during thepuncturing operation relatively easily.

By way of example, by putting a finger on the finger hook projection 62and pushing the finger hook projection 62 in the distal direction, theouter needle 2 can be moved in the distal direction relative to theinner needle 4 relatively easily and assuredly.

In the following exemplary embodiment, description will be made byreferring to the left side in FIGS. 6 to 11 as “distal (end),” the rightside as “proximal (end) (rear end),” the upper side as “upper” and thelower side as “lower.” In addition, in FIGS. 6 to 11, a blood vessel isomitted from drawing.

According to a second embodiment will be disclosed below referringmainly to differences from the above-disclosed first embodiment, anddescriptions of the same items as above will be omitted.

As shown in FIGS. 6 and 7, in the indwelling needle assembly 1 accordingto the second embodiment, a plurality of finger hook projections 62 of apressing member 6 are provided in a main body section 61 along the axisof an outer needle 2. By way of example, in the configuration shown, thefinger hook projections 62 are disposed at regular intervals. The fingerhook projections 62 have the function as graduations indicative of thelength of insertion of the outer needle 2 into a blood vessel, inaddition to the function described in the first embodiment.

In addition, a pressing section 64 in this embodiment is composed ofthat part of the main body section 61 which is located on the oppositeside in the vertical direction from the finger hook projection 62 at thedistal-most end.

By way of example, those parts of the main body section 61 which arelocated on the opposite side in the vertical direction from the fingerhook projections 62 may constitute pressing sections, respectively. Forexample, a predetermined part of a plurality of parts of the outerneedle 2 between the proximal end and the distal end can be selectivelypressed.

The indwelling needle assembly 1 has a grip member 7 which has aproximal portion connected (fixed) to an inner needle hub 5 and whichprotrudes from the inner needle hub 5 in the distal direction. Thishelps ensure that at the time of an operation of putting the outerneedle 2 indwelling in a blood vessel, the grip member 7 can be grippedby hand and the operation can be carried out relatively easily andassuredly.

The grip member 7 is elongated in shape, and is composed of a bottomplate 71 and two wall sections 72 and 73 rising up from the bottom plate71. An inner needle 4 is disposed in a space on the inside of the gripmember 7.

In addition, in the assembled state, the pressing member 6 is containedin the space on the inside of the grip member 7 so as to be movable inthe longitudinal direction thereof. The grip member 7 has a function asa guide member which, when the pressing member 6 is moved in the distaldirection, relatively restricts the moving direction of the pressingmember 6. This helps ensures that when the pressing member 6 is moved inthe distal direction, the pressing member 6 can be prevented from comingout of position in the transverse direction.

By way of example, at outside surfaces of distal portions of the sidewalls 72 and 73, a plurality of ribs 721 and 731 extending in thevertical direction are respectively arrayed as hand slip preventivemeans. This helps ensures that when the grip member 7 is gripped with ahand, the hand can be prevented from slipping.

As shown in FIG. 6, in the assembled state, the pressing member 6 isstored in the space on the inside of the grip member 7.

In addition, in the assembled state, a distal portion of the grip member7 is located on the distal side relative to a proximal portion of theouter needle 2, and is located on the proximal side relative to a distalportion of the inner needle 4.

By way of example, in the assembled state, when the pressing member 6 ispositioned in the first position, the distal portion of the grip member7 is located on the proximal side relative to the distal portion of thepressing member 6.

This helps ensure that a puncturing operation and an operation of movingthe outer needle 2 in the distal direction relative to the inner needle4 can be carried out easily and assuredly.

By way of example, the material constituting the grip member 7 is notrestricted. For example, the same or similar materials as thosementioned as examples of the materials for forming the outer needle hub3 and the inner needle hub 5 above can be used.

An example of the method of using the indwelling needle assembly 1 (inthe case of puncturing a blood vessel) (operation) will be describedbelow.

As shown in FIG. 6, the indwelling needle assembly 1 is put into theassembled state, and the pressing member 6 is positioned in the firstposition. Then, a distal portion of the grip member 7 provided at theinner needle hub 5 is gripped with the right hand (one hand), and anindex finger of the right hand is put on the distal-most finger hookprojection 62 of the pressing member 6. While pressing down the vicinityof a base portion of the finger hook projection 62 by the index finger,a distal portion of the indwelling needle assembly 1 is made to puncturea skin of a patient toward a blood vessel, in such a manner as to pressthe distal portion against the patient. By way of example, the pressingsection 64 presses down that portion of the outer needle 2 between theproximal end and the distal end, whereby the inner needle 4 and theouter needle 2 can be restrained from deflection.

When a needlepoint 41 of the inner needle 4 has punctured a bloodvessel, the internal pressure of the blood vessel causes blood to flowback in the proximal direction through the inner needle 4, to beintroduced into the inner needle hub 5, so that this flashback can bevisually confirmed through the inner needle hub 5 having visibility. Asa result, it can be known that the needlepoint 41 of the inner needle 4has relatively securely punctured the blood vessel.

Next, as shown in FIG. 8, the outer needle 2 is further advanced by aminute distance in the distal direction along the inner needle 4, withthe inner needle 4 as a guide. By way of example, the distal-most fingerhook projection 62 is pushed in the distal direction by the indexfinger, to move the outer needle 2 in the distal direction.

Subsequently, as shown in FIG. 9, the second distal-most finger hookprojection 62 is pushed in the distal direction by the index finger, tomove the outer needle 2 by a minute distance in the distal direction,and such an operation is sequentially repeated to insert a distalportion of the outer needle 2 to a target position in the blood vessel.

Next, as shown in FIG. 10, while holding down by the left hand thepressing member 6 on the side of the outer needle 2 kept indwelling inthe blood vessel, a proximal portion of the grip member 7 and the innerneedle hub 5 are gripped by the right hand and pulled in the proximaldirection. As a result, the inner needle 4 is pulled out of the outerneedle 2. After the inner needle 4 is pulled out of the outer needle 2,if necessary, as shown in FIG. 11( a), the pressing member 6 may bedetached from the outer needle hub 3. Alternatively, as shown in FIG.11( b), the pressing member may be positioned into the second positionby turning. Further, the pressing member 6 may be kept as it is. By wayof example, the subsequent operations are the same as in the firstembodiment, and, therefore, descriptions of the subsequent operationsare omitted.

According to this indwelling needle assembly 1, the same effects asthose of the above-described first embodiment can be obtained.

For example, since the plurality of finger hook projections 62 areprovided along the axis of the outer needle 2 in this indwelling needleassembly 1, by sequentially pushing the finger hook projections 62 inthe distal direction, to move the outer needle 2 in the distal directionrelative to the inner needle 4 relatively easily and assuredly.

In addition, since the grip member 7 is provided, the operation ofputting the outer needle 2 indwelling in a blood vessel can be carriedout relatively easily and assuredly.

In the following example, description will be made by referring to theleft side in FIGS. 12 to 14 and FIGS. 16 to 22 as “distal (end),” theright side as “proximal (end) (rear end),” the upper side as “upper” andthe lower side as “lower.” In addition, in FIGS. 18 to 22, a bloodvessel is omitted from drawing.

A third embodiment will be disclosed below referring mainly todifferences from the above-described second embodiment, and descriptionsof the same items as above will be omitted.

As shown in FIGS. 12, 13, 19 and 20, in the indwelling needle assembly 1according to the third embodiment, the pressing member 6 is configuredto be curved or bent in a direction for coming away from the outerneedle 2, at an intermediate portion in the longitudinal directionthereof. For example, a small material thickness section 611 is formedat an intermediate portion in the longitudinal direction of a main bodysection 61 of the pressing member 6, and the pressing member 6 is curvedor bent through bending deformation of the small material thicknesssection 611. In addition, the small material thickness section 611 isformed at a plurality of locations (in the configuration shown, twolocations) along the longitudinal direction of the main body section 61.Incidentally, the number of the location(s) at which the small materialthickness section 611 is formed may naturally be one.

By way of example, this helps ensure that at the time of moving theouter needle 2 in the distal direction in putting the outer needle 2indwelling in a blood vessel, it is relatively ensured that even if thedistal portion of the pressing member 6 abuts on a predetermined part ofthe patient, the pressing member 6 is curved or bent at its intermediateportion, whereby interference between the pressing member 6 and thepatient's predetermined part can be avoided. As a result, the outerneedle 2 can be moved relatively easily and smoothly. For example, inthe case of puncturing a patient's skin from the inside of an upper armpart and inserting the distal end of the outer needle 2 to a positionimmediately on the operator's side of the patient's side part, a gradualmovement of the pressing member 6 in the distal direction may cause adistal portion of the pressing member 6 to abut on a knot of musclecorresponding to the biceps muscle of arm. By way of example, in such asituation, the pressing member 6 would not be an obstacle, since it iscurved or bent at its intermediate portion.

In addition, the layout of the two small material thickness sections 611is not limited. By way of example, in this embodiment, a setting ofL1<L2 is adopted, where L1 (see FIG. 21) is the length in thelongitudinal direction between the distal end of the pressing member 6and the small material thickness section 611 on the distal side, and L2(see FIG. 21) is the length in the longitudinal direction between thesmall material thickness section 611 on the distal side and the smallmaterial thickness section 611 on the proximal side.

The lengths L1 and L2 are not restricted, respectively, and may beappropriately set according to various conditions. By way of example,the length L1 can be about 10 to 30 mm, for example, about 15 to 20 mm.In addition, the length L2 can be about 20 to 90 mm, for example about30 to 70

MM.

As shown in FIG. 14, a distal portion of the pressing member 6 is soprovided as to be directed upward (in such a direction as to come awayfrom the outer needle 2 in a radial direction of the outer needle 2).For example, the distal portion of the pressing member 6 can be warpedso as to come away from the outer needle 2, which helps ensure that inthe case of moving the outer needle 2 in the distal direction in puttingthe outer needle 2 indwelling in a blood vessel. In addition, it alsohelps ensure that even if the distal portion of the pressing member 6comes into contact with on a predetermined part of the patient, thedistal portion of the pressing member 6 can ride over the predeterminedpart relatively easily and smoothly, whereby the outer needle 2 can bemoved.

As shown in FIG. 15, the indwelling needle assembly 1 has a groove(recess) 65 formed in the pressing member 6, and a groove (recess) 74formed in a grip member 7, as slip-off preventive means for helpingprevent the outer needle 2 from coming out of position in a directionperpendicular to the axis of the outer needle 2, for example, in atransverse direction in FIG. 15.

The groove 65 is formed in a lower surface of the main body section 61of the pressing member 6, and extends along the longitudinal directionof the pressing member 6. By way of example, while the groove 65 isformed over the whole length, from the distal end to the proximal end,of the main body section 61 in the configuration shown, thisconfiguration is not restrictive. For example, the groove 65 may beformed only in a distal portion of the main body section 61.

In addition, the groove 74 is formed in an upper surface of a bottomplate 71 of the grip member 7 at a position corresponding to the groove65, and extends along the longitudinal direction of the grip member 7.For example, while the groove 74 is formed over the whole length, fromthe distal end to the proximal end, of the bottom plate 71 in theconfiguration shown, this configuration is not restrictive. For example,the groove 74 may be formed only in a distal portion of the bottom plate71.

The outer needle 2 is held in the grooves 65 and 74, which helps preventthe outer needle 2 from coming out of position in a transverse directionin FIG. 15.

For example, the groove may be formed in only one of the pressing member6 and the grip member 7.

In addition, as shown in FIG. 16, ribs (engaging sections) 722 and 732projecting sideways to engage with the pressing member 6 can be formedrespectively at inner surfaces of distal portions of wall sections 72and 73 of the grip member 7. The ribs 722 and 732 are so formed as toextend along the longitudinal direction of the grip member 7 and beparallel to each other, which helps ensures that, in the assembledstate, the pressing member 6 can be prevented from being displaced insuch a direction as to come away from the outer needle 2 in a radialdirection of the outer needle 2. For example, the pressing member 6 canbe prevented from being lifted to the upper side. As a result, the statein which the outer needle 2 is inserted in the grooves 65 and 74 isheld, so that the outer needle 2 can be prevented from coming out ofposition in a transverse direction in FIG. 15, as above-mentioned.

By way of example, the grip member 7 has a cover section 75 which isformed at upper portions of the wall sections 72 and 73 and which coversthe space on the inside of the grip member 7. In the configurationshown, the cover section 75 is provided to extend from the proximal endto the distal side relative to a middle portion, of each of the wallsections 72 and 73.

In addition, as shown in FIG. 17, the pressing member 6 can beconfigured to be attachable to and detachable from the outer needle hub3. For example, a shaft 63 provided at a proximal portion of the mainbody section 61 of the pressing member 6 can be detachably attached to abearing 32 provided in the outer needle hub 3. The bearing 32 iscomposed of a pair of C-shaped support sections 321 and 322. By way ofexample, the part of the proximal portion of the main body section 61which is on the distal side of the shaft 63 can protrude in the axialdirection, which helps ensure that when the pressing member 6 ispositioned in the first position shown where it is disposed along theaxis of the outer needle 2, the pressing member 6 cannot be detached.For example, the pressing member 6 can be prevented from beingdisengaged from the outer needle hub 3.

According to another embodiment, when the pressing member 6 is turnedclockwise in the figure to a predetermined position relative to theouter needle 2, the pressing member 6 can be detached.

The pressing member 6 has a pair of stepped sections 661 and 662 formedat that part of the main body section 61 which is on the distal side ofthe shaft 63, as disengagement preventive means, which helps prevent thepressing member 6 from being disengaged from the outer needle hub 3 whenthe pressing member 6 is positioned in the first position shown in FIGS.12 and 17( a) where it is disposed along the axis of the outer needle 2.

The bearing 32 can have a pair of C-shaped support sections 321 and 322.The shaft 63 of the pressing member 6 is attached to and detached fromthe support sections 321 and 322, from and to the right side in FIG. 17.

When the pressing member 6 is positioned in the first position shown inFIG. 17( a) where it is disposed along the axis of the outer needle 2,an attempt to detach the shaft 63 from the support sections 321 and 322by moving the pressing member 6 toward the right side in FIG. 17 fails.For example, the stepped sections 661 and 662 of the pressing member 6come into contact with the support sections 321, 322, so that the shaft63 cannot be detached from the support sections 321, 322. As a result,the pressing member 6 can be prevented from being disengaged from theouter needle hub 3.

In addition, in the case where the pressing member 6 is turned clockwisein FIG. 17 from the first position, before the pressing member 6 becomesperpendicular to the outer needle 2 the shaft 63 of the pressing member6 cannot be detached from the support sections 321 and 322, since thestepped sections 661 and 662 of the pressing member 6 abut on thesupport sections 321 and 322, in the same manner as above-mentioned, asshown in FIG. 17( b).

When the pressing member 6 is turned further clockwise in FIG. 17 andthe pressing member 6 is turned to a predetermined position relative tothe outer needle 2 as shown in FIG. 17( c), the shaft 63 of the pressingmember 6 can be detached from the support sections 321 and 322, as shownin FIG. 17( d).

An example of the method of using the indwelling needle assembly 1 (inthe case of puncturing a blood vessel) (operation) is disclosed below.

As shown in FIG. 12, the indwelling needle assembly 1 is put into theassembled state, and the pressing member 6 is positioned in the firstposition. Then, a distal portion of the grip member 7 provided at theinner needle hub 5 is gripped by one hand, and an index finger is put onthe distal-most finger hook projection 62 of the pressing member 6.While pressing down the vicinity of a base portion of the finger hookprojection 62 by the index finger, a distal portion of the indwellingneedle assembly 1 is caused to puncture a skin of a patient toward ablood vessel, in such a manner as to press the distal portion againstthe patient. By way of example, the pressing section 64 presses downthat part of the outer needle 2 between the proximal end and the distalend, whereby the inner needle 4 and the outer needle 2 can be restrainedfrom deflection.

When the needlepoint 41 of the inner needle 4 has punctured the bloodvessel, the internal pressure of the blood vessel causes blood to flowback in the proximal direction through the inner needle 4, to beintroduced into the inner needle hub 5. This flashback can be visuallyconfirmed through the inner needle hub 5 having visibility. As a result,it can be known that the needlepoint 41 of the inner needle 4 hassecurely punctured the blood vessel.

Next, as shown in FIG. 18, the outer needle 2 is advanced further in thedistal direction along the inner needle 4, with the inner needle 4 as aguide. In this instance, the distal-most finger hook projection 62 ispushed in the distal direction by an index finger, to move the outerneedle 2 in the distal direction. By way of example, when the distalportion of the pressing member 6 comes into contact with a predeterminedpart of the patient, the pressing member 6 is curved or bent at itsintermediate portion, as shown in FIG. 19, which helps ensure that thepressing member 6 would not be an obstacle, and the outer needle 2 canbe moved relatively easily and smoothly.

Subsequently, as shown in FIG. 20, the second distal-most finger hookprojection 62 is pushed in the distal direction by the index finger, tomove the outer needle 2 in the distal direction, and such an operationis sequentially repeated to insert a distal portion of the outer needle2 to a target position in the blood vessel. For example, when thepressing member comes into contact with the patient's predeterminedpart, the pressing member 6 is curved or bent at its intermediateportion, as above-mentioned. As a result, the pressing member 6 wouldnot be an obstacle, and the outer needle 2 can be moved relativelyeasily and smoothly.

Next, as shown in FIG. 21, while holding down by the other hand thepressing member 6 on the side of the outer needle 2 kept indwelling inthe blood vessel, a proximal portion of the grip member 7 and the innerneedle hub 5 are gripped and pulled in the proximal direction, which canresult in the inner needle 4 pulling out of the outer needle 2. Afterthe inner needle 4 is pulled out of the outer needle 2, if necessary, asshown in FIG. 22, the pressing member 6 may be detached from the outerneedle hub 3. Alternatively, the pressing member 6 may be positionedinto the second position by turning. Further, the pressing member 6 maybe kept as it is. Incidentally, the subsequent operations are the sameas in the second embodiment, and, therefore, descriptions of thesubsequent operations are omitted.

According to this indwelling needle assembly 1, the same effects asthose of the above-described second embodiment can be obtained.

Incidentally, while the main body section 61 of the pressing member 6 isformed with the small material thickness section 611 so that thepressing member 6 can be curved or bent in this embodiment, thisconfiguration is not restrictive; for example, a hinge structure sectionincluding a shaft and a bearing for supporting the shaft may be providedat an intermediate portion in the longitudinal direction of the mainbody section 61 of the pressing member 6.

By way of example, in other examples, the pressing member 6 isconfigured to have a shape of being curved or bent at its intermediateportion in the longitudinal direction in a natural state in which noexternal force is exerted on the pressing member 6, and the pressingmember 6 is contained in a rectilinearly stretched state in a space onthe inside of the grip member 7, which helps ensures that when therestraint by the grip member 7 is released, the pressing member 6returns into its original shape before the curving or bending, so thatits interference with a predetermined part of the patient can beobviated.

In addition, while the width of the pressing member 6 has been constantin this embodiment, this is not restrictive; for example, aconfiguration may be adopted in which the width of the pressing member 6is enlarged only at a distal portion, and only the distal portion of thepressing member 6 engages with the ribs 722 and 732. By way of example,when the distal portion of the pressing member 6 is located in aposition corresponding to the ribs 722 and 732, the distal portion ofthe pressing member 6 engages with the ribs 722 and 732 whereby thedistal portion is prevented from being lifted to the upper side. Then,when the pressing member 6 is moved in the distal direction and thedistal portion of the pressing member 6 is located on the distal siderelative to the position corresponding to the ribs 722 and 732, thepressing member 6 and the ribs 722 and 732 are disengaged from eachother, so that the pressing member 6 can be moved upward. For example,the pressing member 6 can move upward before that part of the pressingmember 6 on the proximal side relative to the distal portion isdisengaged from the distal end of the grip member 7.

While the indwelling needle assembly disclosed here has been describedabove based on the embodiments shown in the drawings, the disclosure isnot restricted to the embodiments, and the configuration of eachcomponent can be replaced by one of an arbitrary configuration that hasthe same or equivalent function to the original. Besides, an arbitrarystructure or structures may be added to the configuration of the presentdisclosure.

In addition, the present disclosure may be embodied by a combination ofarbitrary two or more of the above-described embodiments.

By way of example, the indwelling needle assembly according to thepresent disclosure is not limited to the one that is used in the stateof being inserted into a blood vessel. The present disclosure is alsoapplicable, for example, to those to be used in the state of beinginserted into abdominal cavity, thoracic cavity, lymphatic vessel,vertebral canal or the like.

According to the present disclosure, even in the case where an innerneedle and an outer needle are large in length, by pressing down thatpart of the outer needle between the proximal end and the distal endthrough a pressing member, during a puncturing operation, to restrainthe inner needle and the outer needle from deflection. As a result, thepuncturing operation can be carried out easily and assuredly.

In addition, the puncturing operation can be performed while putting afinger on a predetermined part of the pressing member that is nearer tothe distal portions of the inner needle and the outer needle than theinner needle hub and the outer needle hub. Therefore, during thepuncturing operation, the needlepoint of the inner needle can becontrolled relatively easily.

The foregoing embodiments are not intended to restrict the scope of thepresent invention. Various changes, modifications and equivalents couldbe effected by one skilled in the art without departing from the spiritand scope of the invention as defined in the appended claims. It isexpressly intended that all such changes, modifications and equivalents,which fall within the scope of the claims are embraced by the claims.

What is claimed is:
 1. An indwelling assembly comprising: an innerneedle having a sharp needlepoint at a distal end to puncture a bloodvessel of a patient when the indwelling assembly is moved toward thepatient, the inner needle possessing a proximal portion; an inner needlehub fixed to the proximal portion of the inner needle; a hollowelongated outer member in which the inner needle is positioned, thehollow elongated member being movable in a distal direction relative tothe inner needle after puncturing the patient's blood vessel with thesharp needlepoint to position the hollow elongated outer member at adesired position in the blood vessel, the hollow elongated outer memberpossessing a proximal portion; an outer member hub fixed to the proximalportion of the hollow elongated outer member; a projection removablyconnected to the outer member hub and configured to be engaged by afinger of the user to apply a force to the projection causing the outermember hub and the hollow elongated outer member to move together withthe projection in the distal direction relative to the inner needle andthe inner needle hub, the projection being removably connected to theouter member hub so that the projection is detachable from the outermember hub; an elongated movable member that is movable relative to thehollow elongated outer member and the outer member hub, the elongatedmovable member being connected to the inner needle hub so that the innerneedle hub, the inner needle and the elongated movable member movetogether, the elongated movable member projecting in the distaldirection from the inner needle hub; and the elongated movable memberbeing movable together with the inner needle hub and the inner needle ina proximal direction relative to the hollow elongated outer member andthe outer member hub after the hollow elongated outer member ispositioned in the patient's blood vessel to remove the inner needle fromthe patient's blood vessel while the hollow elongated outer memberremains positioned in the patient's blood vessel and to entirely removethe inner needle from the hollow elongated outer member.
 2. Theindwelling assembly according to claim 1, wherein: the hollow elongatedouter member is an outer needle; the outer member hub is an outer needlehub; the projection is a part of a pressing member; and the elongatedmovable member is a grip member.
 3. The indwelling assembly according toclaim 1, wherein at least a portion of the elongated movable member isU-shaped in transverse cross-section, and a portion of the inner needleaxially overlaps the U-shaped portion of the elongated movable member,the portion of the inner needle that axially overlaps the U-shapedportion of the elongated movable member extending from the inner needlehub in the distal direction.
 4. The indwelling assembly according toclaim 3, wherein the proximal portion of the hollow elongated outermember is disposed in the U-shaped elongated movable member.
 5. Theindwelling assembly according to claim 1, wherein the projection isslidable along the elongated movable member.
 6. The indwelling assemblyaccording to claim 1, wherein the proximal portion of the hollowelongated outer member is disposed in the elongated movable member. 7.The indwelling assembly according to claim 1, wherein the elongatedmovable member includes a plurality of spaced apart ribs grippable by ahand of a user to prevent the user's hand from slipping along theelongated movable member.
 8. The indwelling assembly according to claim1, wherein at least a portion of the elongated movable member isU-shaped in transverse cross-section, and wherein the outer member hubaxially overlaps the U-shaped portion of the elongated movable member.9. The indwelling assembly according to claim 1, wherein the innerneedle and the hollow elongated outer member both possess a distal-mostend, and wherein the distal-most end of the inner needle projectsdistally beyond the distal-most end of the hollow elongated outermember.
 10. The indwelling assembly according to claim 1, wherein theelongated movable member is U-shaped in transverse cross-section alongits entire longitudinal extent.
 11. The indwelling assembly according toclaim 10, wherein the U-shaped elongated movable member includes abottom plate and a groove formed in an upper surface of the bottomplate.
 12. The indwelling assembly according to claim 1, wherein atleast a portion of the elongated movable member is U-shaped intransverse cross-section, and a portion of the inner needle axiallyoverlaps the U-shaped portion of the elongated movable member, theportion of the inner needle that axially overlaps the U-shaped portionof the elongated movable member extending from the inner needle hub inthe distal direction.